Premarket Submission Pathways Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Premarket Submission Pathways flashcards as text
Which premarket submission pathway was created by FDARA 2017 to replace the prior 'Expedited Access Pathway' for certain devices?
Answer: Breakthrough Device Program
The Breakthrough Device Program was established under FDARA 2017, superseding the Expedited Access Pathway for breakthrough devices.
For a 510(k), which factor alone would cause FDA to find a device NOT substantially equivalent?
Answer: The device has a different intended use than the predicate
A different intended use automatically results in a Not Substantially Equivalent (NSE) determination for a 510(k) submission.
Under 21 CFR 814.20, a complete PMA application must include which of the following as a mandatory component?
Answer: Proposed labeling sufficient to describe the device's indications
21 CFR 814.20 requires the PMA to include proposed labeling that is sufficient to describe the device, its indications, and directions for use.
A company receives a 'Not Substantially Equivalent' (NSE) decision on its 510(k). What is the NEXT regulatory option to pursue US market authorization?
Answer: File a De Novo request or pursue PMA
After an NSE decision, the sponsor may file a De Novo request if appropriate classification as Class II is possible, or pursue PMA for Class III.
What is the purpose of the Pre-Submission (Q-Sub) program in the context of premarket pathways?
Answer: To allow early FDA feedback on regulatory strategy and study designs before a formal submission
The Q-Sub program provides an interactive mechanism for sponsors to obtain FDA feedback on regulatory strategy, study designs, and data requirements prior to formal submission.
Which of the following best describes the '30-day notice' PMA supplement?
Answer: Used for manufacturing changes where FDA review begins 30 days after submission unless FDA objects
A 30-day notice is for PMA holders making manufacturing process changes; the change can be implemented 30 days after submission unless FDA objects.
An investigational device exemption (IDE) application is required before initiating a significant-risk device clinical study. Which FDA center reviews IDE applications for medical devices?
Answer: CDRH
The Center for Devices and Radiological Health (CDRH) reviews IDE applications for significant-risk medical device investigations.